Refractory EpilepsyBLUELIGHTVNSNCT06304389
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
A study testing electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration and transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration in people with Refractory Epilepsy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration and transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients:
- VNS implanted since at least 3 months age >18-60 years; IQ >55 on Wechsler scale (normal status or mild cognitive impairment)
- healthy participants aged between 18 and 35 years without any medical history (neurological / psychiatric disease)
Who cannot join
- Patients:
- other medical implanted devices than VNS, ocular diseases
- Helthy participants:
- medical implanted devices, cerebral trauma, ocular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Woluwe-Saint-Lambert, 1200
Inci Cakiroglu, Phd student, +32470612917, inci.cakiroglu@uclouvain.be
Inci Cakiroglu, Phd student
About this study
Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.
- Conditions
- Refractory Epilepsy
- Being tested
- electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration, transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administrationOther
Recording of the electrical activity of the brain, of the heart. Pupil size will be analyzed. The effect of blue light administration will be assessed on those parameters.
transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administrationOther
Transcutaneous vagus nerve stimulation will be performed in helathy subjects, as well as the recording of the electrical activity of the brain, and of the heart. Pupil size will be analyzed. The effect of blue light administration will be assessed on those parameters.
| Study group | Role | What they receive |
|---|---|---|
| Patients with refractory epilepsy | Experimental | Patients will not receive any drugs, but will participate to experiments involving electroencephalograpy, pupillometry and light administration. Receives: Other: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration |
| Healthy subjects | Experimental | Subjects will not receive any drugs, but will participate to experiments involving electroencephalograpy, pupillometry and light administration. Receives: Other: transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of blue light on VNS biomarkers
Blue light increases VNS induced electroencephalogram desynchronisation in implanted patients
Measured: 4 years
Effect of blue light on VNS biomarkers
Blue light increases P300 amplitude in VNS implanted patients
Measured: 4 years
Effect of blue light on VNS biomarkers
Blue light increases VNS (or tVNS) induced pupil dilation (in patients \& healthy subjects).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jul 2023
- Primary completion1 Jul 2023
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with refractory epilepsy (divided in non responders \& responders), and healthy subjects
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304389
- Sponsor's protocol ID
- BLUELIGHT-VNS
- Acronym
- BLUELIGHTVNS
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT06304389
- Acronym / sponsor ID
- BLUELIGHTVNS / BLUELIGHT-VNS
- Conditions
- Refractory Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients with refractory epilepsy (divided in non responders \& responders), and healthy subjects
| Arm | Type | Receives |
|---|---|---|
| Patients with refractory epilepsy | Experimental | Other: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administrationPatients will not receive any drugs, but will participate to experiments involving electroencephalograpy, pupillometry and light administration. |
| Healthy subjects | Experimental | Other: transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administrationSubjects will not receive any drugs, but will participate to experiments involving electroencephalograpy, pupillometry and light administration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- VNS implanted since at least 3 months age >18-60 years; IQ >55 on Wechsler scale (normal status or mild cognitive impairment)
- healthy participants aged between 18 and 35 years without any medical history (neurological / psychiatric disease)
Key exclusion criteria (4 listed)
- other medical implanted devices than VNS, ocular diseases
- medical implanted devices, cerebral trauma, ocular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administrationRecording of the electrical activity of the brain, of the heart. Pupil size will be analyzed. The effect of blue light administration will be assessed on those parameters. | Other | Patients with refractory epilepsy |
| transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administrationTranscutaneous vagus nerve stimulation will be performed in helathy subjects, as well as the recording of the electrical activity of the brain, and of the heart. Pupil size will be analyzed. The effect of blue light administration will be assessed on those parameters. | Other | Healthy subjects |
Primary outcome
Effect of blue light on VNS biomarkers
Time frame: 4 years
Blue light increases VNS induced electroencephalogram desynchronisation in implanted patients
Effect of blue light on VNS biomarkers
Time frame: 4 years
Blue light increases P300 amplitude in VNS implanted patients
Effect of blue light on VNS biomarkers
Time frame: 4 years
Blue light increases VNS (or tVNS) induced pupil dilation (in patients \& healthy subjects).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration and transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration in people with Refractory Epilepsy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inci / cakiroglu (+32470612917, inci.cakiroglu@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of blue light on VNS biomarkers (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.